Post Cardiac SurgeryTORQClinNCT01647178
TORQ Clinical Study
A study testing TORQ assisted sternal closure and Conventional closure in people with Post Cardiac Surgery and Sternal Closure, run by Kardium Inc. at 1 site in Canada.
Trial summary
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Cardiac Surgery, Sternal Closure
- What is being tested?
- TORQ assisted sternal closure and Conventional closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for elective cardiac surgery at St Paul's Hospital
- Expected to live greater than 12 months
- Capable of giving written informed consent
- Willing to participate in follow-up
- Greater than 18 years of age, and of legal age of consent in host country
Who cannot join
- Patient has had previous median sternotomy, requiring redo sternotomy
- Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
- Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Conditions
- Post Cardiac Surgery, Sternal Closure
- Being tested
- TORQ assisted sternal closure, Conventional closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORQ assisted sternal closureProcedure or surgery
Also called TORQ (Manufacturer: Kardium, Richmond, Canada)
Conventional closureProcedure or surgery
Also called Straight wire closure
| Study group | Role | What they receive |
|---|---|---|
| Manual closure | Active comparator | Patients are closed with a manual, straight wire, conventional closure technique Receives: Procedure: Conventional closure |
| TORQ closure | Active comparator | Patients are undergo a TORQ assisted sternal closure Receives: Procedure: TORQ assisted sternal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function
Measured: Pre-op, 2 and 4 days Post-op
Pain Score
Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking
Measured: 2, 4, 14, 30 and 90 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Paul's Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- James Abel, MD, Principal investigator, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647178
- Sponsor's protocol ID
- H11-00310
- Acronym
- TORQClin
- Status last verified
- Aug 2015
- First submitted
- 17 Jul 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01647178
- Acronym / sponsor ID
- TORQClin / H11-00310
- Conditions
- Post Cardiac Surgery, Sternal Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Paul's Hospital, Canada
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual closure | Active comparator | Procedure: Conventional closurePatients are closed with a manual, straight wire, conventional closure technique |
| TORQ closure | Active comparator | Procedure: TORQ assisted sternal closurePatients are undergo a TORQ assisted sternal closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referred for elective cardiac surgery at St Paul's Hospital
- Expected to live greater than 12 months
- Capable of giving written informed consent
- Willing to participate in follow-up
- Greater than 18 years of age, and of legal age of consent in host country
Key exclusion criteria (3 listed)
- Patient has had previous median sternotomy, requiring redo sternotomy
- Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
- Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORQ assisted sternal closureAlso: TORQ (Manufacturer: Kardium, Richmond, Canada) | Procedure or surgery | TORQ closure |
| Conventional closureAlso: Straight wire closure | Procedure or surgery | Manual closure |
Primary outcome
Respiratory function
Time frame: Pre-op, 2 and 4 days Post-op
Pain Score
Time frame: 2, 4, 14, 30 and 90 days post op
Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Abel, MD principal investigator
St. Paul's Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TORQ assisted sternal closure and Conventional closure in people with Post Cardiac Surgery and Sternal Closure, run by Kardium Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory function (time frame: Pre-op, 2 and 4 days Post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.